A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study
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A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study

Yoo DH;Hrycaj P;Miranda P;Ramiterre E;Piotrowski M;Shevchuk S;Kovalenko V;Prodanovic N;Abello-Banfi M;Gutierrez-Ureña S;Morales-Olazabal L;Tee M;Jimenez R;Zamani O;Lee SJ;Kim H;Park W;Müller-Ladner U;;
annals of the rheumatic diseases 2013 Vol. 72 pp. -
446
dh2013annalsa

Abstract

CT-P13 demonstrated equivalent efficacy to INX at week 30, with a comparable PK profile and immunogenicity. CT-P13 was well tolerated, with a safety profile comparable with that of INX. CLINICALTRIALS.GOV IDENTIFIER: NCT01217086.

Keywords

National Center for Biotechnology Information NCBI NLM MEDLINE humans pubmed abstract nih national institutes of health national library of medicine treatment outcome research support non-u.s. gov't adult female male adolescent aged middle aged young adult Clinical Trial Phase III Randomized Controlled Trial Antibodies Monoclonal / therapeutic use* Double-Blind Method Multicenter Study severity of illness index drug therapy combination pmid:23687260 pmc3786641 doi:10.1136/annrheumdis-2012-203090 dae hyun yoo pawel hrycaj ulf müller-ladner monoclonal / adverse effects monoclonal / blood antirheumatic agents / adverse effects antirheumatic agents / blood antirheumatic agents / therapeutic use* arthritis rheumatoid / blood rheumatoid / drug therapy* immunoglobulin g / adverse effects immunoglobulin g / blood immunoglobulin g / therapeutic use* infliximab methotrexate / therapeutic use*

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